MDD Biologic Safety
Return to MDD Harmonized Standards

EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process more

EN ISO 10993-03

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity more

EN ISO 10993-04

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood more

EN ISO 10993-05

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity more

EN ISO 10993-06

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation more

EN ISO 10993-07

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals more

EN ISO 10993-09

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products more

EN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity more

EN ISO 10993-12

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials more

EN ISO 10993-13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices more

EN ISO 10993-14

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics more

EN ISO 10993-15

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys more

EN ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables more

EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances more

EN ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of materials more